Volume Restoration of Plantar Pad With a Hyaluronic Acid Dermal Filler in Treatment of Metatarsalgia of Forefeet Further Use of High Heel Shoes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Pain assessment (Time to onset of pain (TInitial) (in hours)
研究概览
简要总结
Aim of this study is to evaluate the decrease of plantar pain of forefeet due to restoration of plantar pad tissue density and of cushioning function with an hyaluronic acid dermal filler as mechanical-supplementation in subjects with metatarsalgia further use of high heel shoes
详细描述
This will be an open and single center study. There will be 4 study visits in total for each subject. Each subject will participate for a period of maximum 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subject aged 30 years or older,
- •Subject with pain sensation under metatarsal heads, further to use of high heels shoes at any moment of the day whatever the onset time,
- •Subject with no previous injections under the metatarsal heads of forefeet.
排除标准
- •Subject with a personal history of allergic/anaphylactic reactions including hypersensitivity to crossed-linked hyaluronic acid and to Lidocaine or amide local anesthetics
- •Subject with cutaneous infection on either foot or with history of autoimmune diseases or auto-inflammatory diseases,
- •Subject who wishes to wear orthotic supports (shock-absorbing insoles or arch supports, etc...).
- •Subject with history of bleeding disorders or or erysipelas of the lower limbs,
- •Subject with chronic inflammatory pain of the feet due to other non-mechanical causes, such as plantar fasciitis, arthritis, gout, Morton's neuroma.
结局指标
主要结局
Pain assessment (Time to onset of pain (TInitial) (in hours)
时间窗: Subject questioning at baseline after injections and change from baseline 1 month after baseline
Time to onset of pain (TInitial) (in hours): duration between beginning of wearing high heel shoes and first pain sensations
Pain assessment (Time to maximum pain tolerance (TEnd)
时间窗: Subject questioning at baseline after injections and change from baseline 1 month after baseline
(in hours): duration between first pain sensations and the maximal pain tolerance (removing shoes).
次要结局
- Podiatric criteria(Change from baseline 6 months after baseline)
- Podiatric criteria (Baro Podometric static examinations)(Change from baseline 6 months after baseline)